Active Bottle for Preterm Infant Oral Feeding

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DESCRIPTION (provided by applicant): Of approximately 4 million live births in the U.S. in year 2000, 11.6 percent or about 471,000 infants were born less than 37 weeks gestation (Martin et al). Preterm infants may spend days or weeks in a neonatal intensive care unit (NICU), where they are nutritionally supported by nasogastric feeding tube, until they are capable of oral feeding by means of sucking and swallowing and can digest human milk or formula (Schanler & Lau). For otherwise healthy preterm infants, oral feeding difficulty is the single most important determinant of prolonged stays in intensive care (Eichenwald et al). Serious health consequences can result from persistent oral feeding problems, including malnutrition and impaired intellectual growth (Jones, Morgan & Shelton). Moreover, it is estimated that in the U.S., the cost of neonatal intensive care ranges between 50,000 and 100,000 dollars per patient (Zupancic et al). A reduction in number of NICU days associated with oral feeding difficulty could substantially reduce this cost and the risk of feeding-related health problems. The Phase II will undertake a clinical research program to evaluate both safety and proof-of-concept of a computer-controlled active bottle milk delivery system developed and tested in the laboratory during the Phase I. This system is designed to promote coordination of breathing with sucking and swallowing and to reduce the number of days that preterm infants remain in intensive care. Engineers at Infoscitex will provide the necessary active bottle systems, including bottles, electronics and control, and disposable components to conduct the clinical research at Children's Hospital Boston (CHB) and Beth Israel Deaconess Medical Center (BIDMC). Subjects will be 32 infants receiving care in the Neonatal Intensive Care Units (NICUs) at CHB and BIDMC, who are 32 to 34 weeks post conceptional age at the first test and are healthy except for their early birth. In addition, the Phase II project team will work with caregivers to conduct a human factors evaluation of the active bottle design.